Affiliation : Indiana University
Goal: The goal of the CTSI Investigational Agent Acquisition Program (IAAP) is to assist CTSI investigators seeking investigational agents for use in clinical trials.
Scope: The IAAP program will assist in acquiring drugs, neutraceuticals, biologics or other materials to be used in a Investigational New Drug Application or IND-exempt clinical trial.
Eligibility: Any faculty within the CTSI member institutions.
Overview: Moving bench research into the clinic has a variety of hurdles. One challenge repeatedly identified by investigators is the acquisition of novel products of interest that are suitable for use in clinical trials. For the most part, investigators have little or no experience in the regulatory requirements for an investigational agent; nor do they have expertise in identifying suitable vendors who can manufacture the required material.
The manufacture of some materials, such as neutraceuticals, are generally straightforward and the IAAP can utilize its expertise to generate a roadmap and identify vendors for an investigator to consider. In other cases, for example when suitable active pharmaceutical ingredient (API) is not available, the manufacturing process is highly specialized, the properties of the material are not well characterized, or significant work will be required in defining a manufacturing plan and identifying a suitable production facility, consultants with specific experience must be engaged.
The IAAP will meet with investigators, assess their needs and either facilitate the acquisition process or facilitate the hiring of outside consultants skilled in product acquisition. While advice will be provided, ultimately any decisions regarding the manufacturing plan and the acceptability of the material generated lies with the principle investigator. Therefore, users of the IAAP are expected to drive the process, providing requested information in a timely manner and maintain active interactions with consultants and manufacturers.
- Develop a roadmap for acquisition including production plan consistent with current FDA regulations
- Coordinate communication with suitable vendors and assist with negotiations
- Facilitate hiring commercial product procurement organization to manage drug acquisition, when required
- Provide recommendations regarding appropriate documentation required to assure product quality and satisfy FDA requirements
- Facilitate coordination with Investigational Drug Pharmacy to store and dispense material under relevant Federal and State regulations
- Monitor progress throughout the project and address roadblocks
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- Is an Investigational New Drug (IND) Application Required? (University of Michigan)
- Does my study need an IND? (Boston Children
- Review of Drugs, IND Requirements (Virginia Commonwealth University)
- FDA Guidelines for IND Applications: 21.312.1
- FDA Guidelines for IND Applications: 21.312.2
- FDA Guidelines for IND Applications: 21.312.3
- FDA Nutraceutical Final Rule
- FDA fact sheet regarding Final Rule